Consumption expands the requirements for the sale of hygienic masks and regulates those that allow lip reading

The Minister of Consumer Affairs, Alberto Garzón, today signed the Ministerial Order establishing the information and marketing requirements for hygienic masks. After obtaining the mandatory authorizations from the World Trade Organization (WTO) and the European Union (EU), Spain thus strengthens its regulations, limiting the concept of hygienic mask and including regulation for those that allow lip reading to people with hearing disabilities . This definition serves to establish which products can be marketed as such and the technical requirements that must be met.

With this order, which will come into force with its publication in the Official State Gazette (BOE), Consumption deepens the obligations of labeling and marketing. From now on, for the mask to be marketed as hygienic, it will have to be tested in accredited laboratories that certify these characteristics. Likewise, the order incorporates actions by the market surveillance authorities to comply with the new regulations.

Additional requirements for masks, accessories and filters

With the order in force, all hygienic masks must indicate on their packaging what standards, technical specifications, work agreements or other technical documents of a recognized standardization body have been followed for the manufacture of the final product or its materials.

They will also indicate the data tested on the filtration efficiency of the material, the resistance to breathing or air permeability and the laboratory used to carry it out. In reusable products, the data obtained before and after the washing cycles indicated by the manufacturer must appear.

The data indicated must always refer to the final good placed on the market and the economic operator will be responsible for the traceability of the product, as well as for the laboratory to comply with its obligations. Likewise, you must indicate the place of origin of the product when its omission may lead to error. In no case may the labeling include references to other types of products that give rise to deception about the nature of the product.

The commercialization of hygienic masks outside the original packaging is also prohibited, as well as in any other format that does not guarantee compliance with the requirements of the Order.

In relation to the filters sold separately from the rest of the fabric that makes up the mask, the obligation to cover the largest possible surface and without areas through which the inhaled and exhaled air can pass without filtering is included. You will also need to specify which specific fabric has been used to obtain the bacterial filtration and breathability data. The mask-filter set must comply with the standard.

Lip reading, psychomotor difficulty and children's masks

Exceptionally, in masks that have parts intended to allow lip reading and that do not facilitate the passage of inhaled or exhaled air, it will be allowed that the indicated particle filtration efficiency does not refer to those areas, provided that it is indicated in the own label. However, these masks must meet other additional requirements such as allowing a clear vision without fogging, ensuring that the product does not obstruct breathing and must indicate on the label if there is a distorting effect on speech.

In the case of hygienic masks intended for people with disabilities, they must have adjustable elements with velcro on the head to prevent chafing behind the ears, with adapters (ear savers), or with any other element that facilitates the autonomy of people with difficulties. psychomotor.

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For children's masks, the labeling must reflect the approximate age of use, based on the anthropometric data of the Spanish population, as well as the indication: "Warning: Use under the supervision of an adult". As for their manufacture, they must also comply with the technical specifications UNE-EN 14682:2015. AND

Obligations for laboratories and market surveillance

The certification laboratories must have implemented, at least for the tests, a system in accordance with the UNE-EN ISO/IEC standard and be accredited by the national entity corresponding to the country where it is located. This is a strict and equivalent requirement, but not identical, to the one that has been required until now of laboratories that certify personal protective equipment (PPE).

The market surveillance authorities will be able to verify both that the masks on the market comply with the content of the order and that the testing laboratories have sufficient competence. They may require all the information about the product and the tests carried out. They may also request the training of personnel and any other aspect that may be necessary to guarantee the correct performance of the tests and the results obtained.

Transitional period and sanctions

The content of the order will enter into force the day after its publication in the BOE. The masks that have been put on the market previously will have a period of 30 days to adapt. After this period they can no longer be marketed under the name of hygienic masks.

Likewise, the laboratories that certify the characteristics of the masks will have six months for accreditation before the corresponding national authority, a minimum period to carry out the procedures. However, to guarantee the control of the laboratories during the transitional period, they must prove that they have implemented the UNE regulations and that they have requested their accreditation before the national authority. Laboratories are not exempt from the obligation to be complying with the standard during the transitional period, but rather they have to demonstrate that they are in the process of obtaining the corresponding certificate.

For this, they will issue a certification to the company that requests their services and must attach the accreditation request, a confirmation of the complete delivery of the request and the payment of the fees.

In accordance with the General Law for the Defense of Consumers and Users, non-compliance with the regulations relating to labeling, packaging and advertising of goods and services constitutes an infringement. The Autonomous Communities can initiate sanctioning proceedings against companies that market masks without respecting the labeling regulations and withdraw the products from circulation.

Since the entry into force of the order, laboratories that certify the characteristics of hygienic masks without complying with the provisions of the standard are exposed to being sanctioned with five-year closures.

Regulations in the EU

In addition to Spain, different European countries have developed their own technical specifications on hygienic masks. The European Committee for Standardization (CEN) has taken these requirements into account to prepare the CWA 17553/2020 standard, which serves as a guide to establish the minimum requirements for hygienic masks to ensure the limitation of the risk of contagion. It is a voluntary agreement and, therefore, there is no European harmonized regulation in this regard. For this reason, some member states have chosen either to regulate or to prohibit the use of hygienic masks in certain spaces.

In France, since January 27, the marketing of masks for non-sanitary use has been prohibited. Likewise, the use in schools of non-surgical masks, FFP2, or type 1 hygienic masks (filtration greater than 90%) has been prohibited. That is to say, what in Spain will be called hygienic masks from the entry into force of this order, corresponds to the French type 1 hygienic masks that are not prohibited. Those that have been prohibited in France, in Spain cannot be called hygienic, because there are more demanding regulations.

The European Commissioner for Health and Consumer Affairs, Stela Kyriakides, based on the examinations of the European Center for Disease Prevention and Control (ECDC), indicated on February 3 that there is not enough evidence to recommend the use of masks. FFP2 for the general public. The recommendation for the healthy population without contact with the virus is the use of a hygienic mask that meets the standards of the CWA 17553 technical standard, as it is now regulated in Spain.

In April 2020, Consumer Affairs approved the order that established the labeling and marketing requirements for all masks that were not considered surgical or FFP. Due to the lack of stock in that phase of the pandemic, the standard covered all those of the UNE regulations and those of similar standards, but without the obligation of bacterial respiration or breathability efficacy tests.

At this time, after the adaptation of the national industry, Spain covers 90% of the demand and all the market surveillance work. For this reason, and with the new varieties of masks and accessories, Consumption expands the requirements of this product to guarantee the safety of people without symptoms of coronavirus and who are not in contact with sick people.